Validation Lead
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
- Lead the daily operations of the Validation function, managing Validation Engineers (staff and outsourced providers), coordinating activities, and improving operational efficiency.
- Ensure facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning procedures, analytical methods, and aseptic operations perform as intended and reliably produce safe, effective, and compliant biopharmaceutical products.
- Provide strategic leadership across the validation lifecycle—planning, execution, review, approval, and maintenance—aligned with GMP, data integrity principles, and risk‑based methodologies. Own the Site Validation Master Plan (VMP), champion cross‑functional governance, and drive continuous improvement to maintain a validated state.
Role and Responsibilities
- Lead and develop the Validation team; foster an engaged, psychologically safe, high‑performance culture aligned with Astellas values.
- Ensure stable supply and delivery of departmental objectives; resolve issues, prioritise effectively, and drive continuous improvement via ambitious KPIs.
- Maintain compliance with GMP, GDP, environmental, safety, and governance requirements; ensure audit readiness and robust data integrity.
- Contribute to site and global strategy; deliver strategic projects on time and within budget while anticipating future trends and skill needs.
- Lead implementation of new products, technologies, systems, and procedures; ensure compliant change management and effective knowledge transfer.
- Build strong cross‑functional and global partnerships; support business continuity, mitigate risks, and deputise for site leaders as required.
Required Qualifications
- Bachelor’s degree (or equivalent) in an Engineering or Scientific discipline, or proven relevant in‑depth experience.
- Preferred Qualifications
- Extensive experience in a similar role with strong technical competence and validation leadership capability (cGMP start‑up experience advantageous).
- Proven ability to progress complex technical projects, support commissioning/maintenance of cGMP manufacturing, and manage multiple priorities.
- Excellent organisational, interpersonal, verbal, and written communication skills; able to work independently and collaboratively; open to new ideas.
What awaits you at Astellas?
Global collaboration: Become part of a connected global business of like‑minded life science leaders, all dedicated to improving patients' lives.
Real‑world patient impact: Contribute to transformative therapies that reach patients around the world.
Relentless innovation: Join a company at the forefront of scientific breakthroughs.
A culture of growth: Thrive in a supportive environment that champions your development.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Learn more: https://www.astellas.com/en/careers
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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